Clinical Trial System Manager

Description

Cedar Health Research is a clinical trial site & patient network based in Dallas, Texas. We are seeking a Clinical Trial Management Systems (CTMS) Manager.  This is a vital role that requires a self motivated individual who is experienced in the clinical trial industry and understands the needs of clinicians, trial managers and sponsors alike. The right candidate will be able to become the SME of our CTMS and take full ownership of the day to day functionality, as well more long term strategic initiatives as well.

CTMS RESPONSIBILTIES: 

• Manage the setup of new studies in RealTime  & Devana
• Support the collection of essential documents necessary for site activation.
• Primary liaison and point of contact for RealTime
• Monitor and evaluate post process implementation of site specific or CTMS projects performance and implement changes if necessary
• Work with the clinical and management staff to Identify requirements and develop operational and CTMS report needs.
• Review and approval of all costs related to CTMS updates, usage and enhancements
• Interact and support of cross functional departments (Clinical, Finance, Recruitment)
• In CTMS oversee closeout functions on completed studies
• Work operational tasks, as well as strategic initiatives in support of CTMS end users, technical support and organizational leadership
•  Accurate building and setup of budgets in CTMS based on study protocol

Clinical Trial-Specific Responsibilities:

• Support all stages of trial conduct beginning with study design, study start-up, patient visits, and trial close-out.
• Help to ensure trial activities are completed in compliance with Code of Federal Regulations (CFR), ICH/GCP guidelines, local regulatory requirements, and company SOPs when regarding business operations.
• Assist with the submission, tracking and maintenance of clinical trials in CTMS.
• Ensure inspection readiness is maintained for all trials; CTMS Audit
• Interact with clinical trial sites, and vendors as well as internal functions and management to resolve inquiries, including reconciliations, analytics, and other requests.
• Participate in the review of trial related documents including protocols, informed consent forms, CTA, Budget review, and clinical study reports.
• Enhance and refine workflow processes and methodologies in CTMS. Trains others in work management skills.

Qualifications

Skills & Experience:

• Minimum of 2-4 years of experience in the clinical trial industry
• Sound knowledge of the financial and budget aspects of a Clinical Trial Management System
•  Preferred 2-3 years’ experience working with Real Time CTMS
• Familiarity with Salesforce and preferably Devana
• Advanced User of Microsoft Office (WORD, Excel, Power Point)
• Comfortable working in fast paced clinical trial administration environment  

Salary Commensurate with Experience